BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRUE-TRAC, STRATUS

    K Number: K926316 · Decision Mar 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    44
    Review Days
    99

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    Basic Information

    Device Name
    TRUE-TRAC, STRATUS
    K Number
    K926316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Henley Intl.
    Date Received
    December 15, 1992
    Decision Date
    March 24, 1993
    Product Code
    JFB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JFB Table, Physical Therapy, Multi Function

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    K915864 MONOTRODE CUTANEOUS ELECTRODE
    K922036 SONOPULS 591
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